Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer's Disease (REFLECT-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00348140
First received: June 30, 2006
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.


Condition Intervention Phase
Alzheimer's Disease
Drug: Rosiglitazone Extended Release 2mg
Drug: Rosiglitazone Extended Release 8mg
Other: Placebo
Other: Donepezil
Other: Galantamine
Other: Rivastigmine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 54-week, Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy to Acetylcholinesterase Inhibitors on Cognition and Overall Clinical Response in APOE e4-stratified Subjects With Mild to Moderate Alzheimer's Disease (REFLECT-3)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in ADAS-Cog total score and CDR-Sum of Boxes score at Week 48, as a function of APOE e4 status. [ Time Frame: At visits between Week 4 and 48 ]

Secondary Outcome Measures:
  • At visits between Week 4 and 24: Assessments of changes in behavior, activities of daily living, healthcare resource utilization, subject and caregiver quality of life, pharmacokinetics, exploratory pharmacogenetics, proteomics, and transcriptomics. [ Time Frame: At visits between Week 4 and 48 ]
  • Assessments of changes in behavior, activities of daily living, healthcare resource utilization, subject and caregiver quality of life, pharmacokinetics, exploratory pharmacogenetics, proteomics, and transcriptomics. [ Time Frame: At visits between Week 4 and 48 ]
  • Secondary endpoints include measures of: Cognition and function: MMSE, Neuropsychiatric Inventory (NPI), DAD. [ Time Frame: At visits between Week 4 and 48 ]
  • Health Outcomes: Resource Utilization in Dementia (RUD), European Quality of Life -5 Dimensions (EQ-5D), Alzheimer's Carer's Quality of Life Instrument (ACQLI). [ Time Frame: At visits between Week 4 and 48 ]

Enrollment: 1450
Study Start Date: July 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Rosiglitazone Extended Release 2mg OD
Drug: Rosiglitazone Extended Release 2mg
Rosiglitazone Extended Release 2mg OD
Other: Donepezil
Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Other: Galantamine
Galantamine (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Other: Rivastigmine
Rivastigmine (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Experimental: Arm 2
Rosiglitazone Extended Release 8mg OD
Drug: Rosiglitazone Extended Release 8mg
Rosiglitazone Extended Release 8mg OD
Other: Donepezil
Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Other: Galantamine
Galantamine (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Other: Rivastigmine
Rivastigmine (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Placebo Comparator: Arm 3
Placebo
Other: Placebo
Placebo
Other: Donepezil
Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Other: Galantamine
Galantamine (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).
Other: Rivastigmine
Rivastigmine (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months and with no intent to change for the duration of the study).

Detailed Description:

A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-3)

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

  • Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2).

(Note: National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).)

  • Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 26 inclusive at Screening.
  • Hachinski Ischemia Score ≤ 4 at Screening (See Appendix 3).
  • Age ≥50 and ≤90 years.
  • At least 6 months of ongoing acetylcholinesterase inhibitor therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
  • Current use of medication is in accordance with the criteria listed in Table 2 (Permitted Medications, Section 8.1).
  • Female subjects must be post-menopausal (i.e. >1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception (Appendix 4) for the duration of the study. Female subjects who are pre-menopausal or who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) at Visit 1, which must be negative.
  • Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease.

(Note: Questionable CT or MRI scans should be discussed with the medical monitor, using central imaging guidelines.)

  • Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma).
  • Subject has the ability to comply with procedures for cognitive and other testing.
  • Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.

(Note: A non-cohabiting caregiver must spend sufficient time with the subject so that, in the opinion of the Investigator, the caregiver can reliably assess cognitive function, activities and behavior, and report on the subject's compliance and health. As caregiver time spent with a potential subject is anticipated to be highly variable across countries and cultures, GSK will consider a variety of different measures by which this stipulation may be met, and GSK should be consulted if adequacy of a caregiver situation is in doubt. However, as guidance, the ability for a caregiver to meet his/her expected responsibilities for this study would normally be possible when the caregiver spends no less than 10 hours per week with the subject, divided over multiple days.)

  • Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.

(Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)

  • Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
  • Subjects considered for enrolment must have a QTc (either QTc B (Bazett's correction) or QTc F (Fridericia's correction)) <450msec at Visit 1, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be <480msec).

(Note: For the purposes of these criteria, QTc B is defined as (QT interval [msec]) / (square root of RR interval [seconds]); and QTc F is defined as (QT interval [msec]) / (cube root of RR interval [seconds]).)

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 5).

(Note: National Institute of Neurological Disorders and Stroke (NINDS) and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN).)

  • History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
  • Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH), that are clinically significant in the opinion of the investigator.

(Note: Testing is required for each parameter only when no result is available from previous 12 months.)

  • History of Type 1 diabetes mellitus or secondary diabetes mellitus.
  • Type 2 diabetes mellitus where the subject is being treated with insulin, a PPARγ agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
  • Any patient with an HbA1c ≥8.5%. (See Section 6.3.8.4 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus.)
  • History or clinical/investigational evidence of congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status; Appendix 6).
  • History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
  • History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment.

(Note: If not currently treated, but active depression is suspected, the Cornell Scale for Depression in Dementia (CSDD, Appendix 7) can be used by the Investigator as a guide for deciding whether a prospective subject requires treatment. If the subject has a CSDD score >7, the Investigator should decide if the subject has depression in need of prescribed medication, and a CSDD >12 is considered a strong indicator that treatment is needed. Subjects will be allowed to re-screen after their depression has been adequately managed for >3 months.)

  • History or presence of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
  • Clinically significant peripheral edema at the time of screening.
  • Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia.
  • Systolic blood pressure >165 or <90 mmHg or diastolic blood pressure >95 or <60 mmHg at the time of screening.
  • Clinically significant anemia (i.e. hemoglobin <11 g/dL for males or <10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA1c.
  • Abnormal kidney function tests (>1.5 times the upper limit of normal (ULN)).
  • ALT, AST, or alkaline phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C).

(Note: For subjects with a diagnosis of Gilberts Syndrome and an isolated increase in total bilirubin >1.5 ULN, fractionation should be performed. If all of the following conditions are met, the patient may enter or remain in the study, even if total bilirubin >1.5 ULN:

  • an elevated unconjugated (indirect) bilirubin;
  • the percentage of direct bilirubin <35%;
  • ALT, AST, and alkaline phosphatase <2.5 ULN if subject is in screening (<2.0 ULN for Canadian subjects only), or ≤3 ULN if subject is already randomized into the study)
  • History of a bone marrow transplant.
  • Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study or is at risk of non-compliance with study medication or procedures.
  • Subject is an immediate family member or employee of the participating Investigator, of any of the participating site staff, or of GSK.
  • In France, a subject is neither affiliated with nor a beneficiary of a social security category.
  • The French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).
  • Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Screening, as well as for the duration of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348140

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Sun City, Arizona, United States, 85351
GSK Investigational Site
Tucson, Arizona, United States, 85741
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Laguna Hills, California, United States, 92653
GSK Investigational Site
Redlands, California, United States, 92374
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Francisco, California, United States, 94109
United States, Connecticut
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
GSK Investigational Site
Deerfield Beach, Florida, United States, 33064
GSK Investigational Site
Delray Beach, Florida, United States, 33445
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Hialeah, Florida, United States, 33016
GSK Investigational Site
Ocala, Florida, United States, 34471
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
GSK Investigational Site
Tampa, Florida, United States, 33617
United States, Georgia
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60610
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01104
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
United States, New Jersey
GSK Investigational Site
Eatontown, New Jersey, United States, 07724
GSK Investigational Site
Manchester, New Jersey, United States, 08759
GSK Investigational Site
Toms River, New Jersey, United States, 08755
United States, New York
GSK Investigational Site
Amherst, New York, United States, 14226
GSK Investigational Site
New York, New York, United States, 10032
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
Rochester, New York, United States, 14620
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Centerville, Ohio, United States, 45459
GSK Investigational Site
Columbus, Ohio, United States, 43210
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
GSK Investigational Site
Jenkintown, Pennsylvania, United States, 19046
GSK Investigational Site
Norristown, Pennsylvania, United States, 19401
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22903
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98108
United States, Wisconsin
GSK Investigational Site
Middleton, Wisconsin, United States, 53562-2215
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
GSK Investigational Site
Hornsby, New South Wales, Australia, 2077
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
GSK Investigational Site
Chermside, Queensland, Australia, 4032
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Australia, Victoria
GSK Investigational Site
Cheltenham, Victoria, Australia, 3192
GSK Investigational Site
Heidelberg West, Victoria, Australia, 3084
GSK Investigational Site
Kew, Victoria, Australia, 3101
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Kortrijk, Belgium, 8500
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Woluwe-Saint-Lambert, Belgium, 1200
Bulgaria
GSK Investigational Site
Sofia, Bulgaria, 1113
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Varna, Bulgaria, 9010
Canada, British Columbia
GSK Investigational Site
Kelowna, British Columbia, Canada, V1W 4V5
Canada, New Brunswick
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 3L6
Canada, Nova Scotia
GSK Investigational Site
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
GSK Investigational Site
Kingston, Ontario, Canada, K7L 5G2
GSK Investigational Site
Ottawa, Ontario, Canada, K1G 4G3
GSK Investigational Site
Ottawa, Ontario, Canada, K1N 5C8
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 2P4
GSK Investigational Site
Toronto, Ontario, Canada, M3B 2S7
GSK Investigational Site
Toronto, Ontario, Canada, M6M 3Z5
Canada, Quebec
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2J2
GSK Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
GSK Investigational Site
Montreal, Quebec, Canada, H4H 1R3
GSK Investigational Site
Québec, Quebec, Canada, G1R 3X5
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1J 3H5
Czech Republic
GSK Investigational Site
Olomouc, Czech Republic, 775 20
GSK Investigational Site
Praha 10, Czech Republic, 10000
GSK Investigational Site
Praha 8, Czech Republic, 180 00
GSK Investigational Site
Trutnov, Czech Republic, 541 01
Finland
GSK Investigational Site
Helsinki, Finland, 00120
GSK Investigational Site
Joensuu, Finland, 80100
GSK Investigational Site
Kuopio, Finland, 70211
France
GSK Investigational Site
Bordeaux, France, 33076
GSK Investigational Site
La Chapelle sur Erdre, France, 44240
GSK Investigational Site
La Seyne sur Mer, France, 83500
GSK Investigational Site
Lille, France, 59000
GSK Investigational Site
Limoges, France, 87042
GSK Investigational Site
Metz, France, 57000
GSK Investigational Site
Nantes, France, 44000
GSK Investigational Site
Nantes, France, 44300
GSK Investigational Site
Paris, France, 75013
GSK Investigational Site
Sautron, France, 44880
GSK Investigational Site
Toulon, France, 83000
GSK Investigational Site
Toulouse, France, 31300
GSK Investigational Site
Valence, France, 26000
Germany
GSK Investigational Site
Aalen, Baden-Wuerttemberg, Germany, 73430
GSK Investigational Site
Calw, Baden-Wuerttemberg, Germany, 75365
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70176
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
GSK Investigational Site
Wiesloch, Baden-Wuerttemberg, Germany, 69168
GSK Investigational Site
Alzenau, Bayern, Germany, 63755
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Unterhaching, Bayern, Germany, 82008
GSK Investigational Site
Bad Saarow, Brandenburg, Germany, 15526
GSK Investigational Site
Bad Homburg, Hessen, Germany, 61348
GSK Investigational Site
Erbach, Hessen, Germany, 64711
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09111
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzig, Sachsen, Germany, 04157
GSK Investigational Site
Leipzig, Sachsen, Germany, 04107
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Gera, Thueringen, Germany, 07551
GSK Investigational Site
Jena, Thueringen, Germany, 07743
GSK Investigational Site
Berlin, Germany, 12167
GSK Investigational Site
Berlin, Germany, 13357
GSK Investigational Site
Berlin, Germany, 13507
GSK Investigational Site
Berlin, Germany, 12555
GSK Investigational Site
Berlin, Germany, 13187
GSK Investigational Site
Berlin, Germany, 10625
GSK Investigational Site
Berlin, Germany, 14163
GSK Investigational Site
Berlin, Germany, 13156
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 13439
GSK Investigational Site
Berlin, Germany, 13053
GSK Investigational Site
Berlin, Germany, 12163
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Korea, Republic of
GSK Investigational Site
Seongnam-si,, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 150-713
Malaysia
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 50586
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 59100
GSK Investigational Site
Ipoh, Malaysia, 30990
GSK Investigational Site
Kelantan, Malaysia, 16150
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Blaricum, Netherlands, 1261 AN
GSK Investigational Site
Den Bosch, Netherlands, 5232 JL
GSK Investigational Site
Den Haag, Netherlands, 2545 CH
GSK Investigational Site
Hengelo, Netherlands, 7555 DL
GSK Investigational Site
Hilversum, Netherlands, 1213 XZ
Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Pasig City, Philippines, 1600
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-796
GSK Investigational Site
Krakow, Poland, 31-530
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Warsaw, Poland, 02-097
Singapore
GSK Investigational Site
Singapore, Singapore, 308433
GSK Investigational Site
Singapore, Singapore, 169608
GSK Investigational Site
Singapore, Singapore, 539747
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 811 07
GSK Investigational Site
Bratislava, Slovakia, 811 01
GSK Investigational Site
Bratislava, Slovakia, 825 56
GSK Investigational Site
Kosice, Slovakia, 041 66
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
Šempeter, Slovenia, 5290
South Africa
GSK Investigational Site
Loeventstein, South Africa, 7530
GSK Investigational Site
Oakdale, South Africa, 7530
GSK Investigational Site
Richards Bay, South Africa, 3900
GSK Investigational Site
Rosebank, South Africa, 2196
GSK Investigational Site
Somerset West, South Africa, 7130
GSK Investigational Site
Waverley, Bloemfontein, South Africa, 9301
GSK Investigational Site
Willows, X14, Pretoria, South Africa, 0040
Spain
GSK Investigational Site
Baracaldo/Vizcaya, Spain, 48903
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08907
GSK Investigational Site
Barcelona, Spain, 08014
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
Sweden
GSK Investigational Site
Falköping, Sweden, SE-521 85
GSK Investigational Site
Jönköping, Sweden, SE-551 85
GSK Investigational Site
Kalix, Sweden, SE-952 82
GSK Investigational Site
Mölndal, Sweden, SE-431 41
GSK Investigational Site
Sundsvall, Sweden, SE-851 86
GSK Investigational Site
Umeå, Sweden, SE-901 85
United Kingdom
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY2 0JH
GSK Investigational Site
Bradford, United Kingdom, BD3 0DQ
GSK Investigational Site
Liverpool, United Kingdom, L9 7LJ
GSK Investigational Site
Stirling, United Kingdom, FK8 1RW
GSK Investigational Site
West End, Southampton, United Kingdom, SO30 3JB
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00348140     History of Changes
Other Study ID Numbers: AVA102670
Study First Received: June 30, 2006
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
adjunctive therapy
moderate
Alzheimer's disease
apolipoprotein E
mild
rosiglitazone
cognition

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Cholinesterase Inhibitors
Donepezil
Galantamine
Rivastigmine
Rosiglitazone
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Nootropic Agents
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014